Molecularly Targeted Theranostic Approach for the Detection and Treatment of Metastatic Carcinomas
NCT ID: NCT06389123
Last Updated: 2024-12-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
40 participants
INTERVENTIONAL
2024-04-01
2028-03-31
Brief Summary
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Detailed Description
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The hypothesis are that a) \[68Ga\]Ga DOTA-5G will detect lesions in patients with metastatic cancer, b) the theranostic pair \[68Ga\]Ga DOTA-5G/ \[177Lu\]Lu DOTA-ABM-5G will be safe and well tolerated, and c) a therapeutic response will be achieved with a single dose of \[177Lu\]Lu DOTA-ABM-5G.
Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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[177Lu]Lu DOTA-ABM-5G single dose therapy study
Patients will be undergo \[68Ga\]Ga DOTA-5G PET/CT scans to confirm eligibility for the \[177Lu\]Lu DOTA-ABM-5G therapy. Patients with sufficient lesion uptake of \[68Ga\]Ga DOTA-5G PET/CT will be offered therapy.
[68Ga]Ga DOTA-5G and [177Lu]Lu DOTA-ABM-5G.
Patients will be undergo \[68Ga\]Ga DOTA-5G PET/CT scans to confirm eligibility for the \[177Lu\]Lu DOTA-ABM-5G therapy. Patients with sufficient lesion uptake of \[68Ga\]Ga DOTA-5G PET/CT will be offered therapy. Patients will undergo a follow up \[68Ga\]Ga DOTA-5G PET/CT scans to assess tretament efficacy.
Interventions
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[68Ga]Ga DOTA-5G and [177Lu]Lu DOTA-ABM-5G.
Patients will be undergo \[68Ga\]Ga DOTA-5G PET/CT scans to confirm eligibility for the \[177Lu\]Lu DOTA-ABM-5G therapy. Patients with sufficient lesion uptake of \[68Ga\]Ga DOTA-5G PET/CT will be offered therapy. Patients will undergo a follow up \[68Ga\]Ga DOTA-5G PET/CT scans to assess tretament efficacy.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Age 18 or more years
3. Pathologically confirmed GU, GI, breast, cervical, uterine, or head and neck cancers with metastatic disease and measurable disease per RECIST (version 1.1) (i.e. at least 1 lesion \> 1 cm or lymph node \> 1.5 cm in short axis)
4. Participant must have documented tumor progression for metastatic disease during or following at least one prior FDA approved systemic regimen (Androgen Deprivation allowed) as established by diagnostic imaging.
5. Available archival tumor tissue (excisional, core, or FNA is acceptable). Tissue from a metastatic site is preferred when available.
6. Eastern Cooperative Oncology Group Performance Status ≤ 2
7. Participant must have completed prior systemic therapy at least 2 weeks (washout period) prior to \[68Ga\]Ga DOTA-5G PET scan. Any clinically significant toxicity (with the exceptions of hair loss and sensory neuropathy) related to prior therapy resolved to Grade 1 or baseline.
8. Hematologic parameters defined as:
Absolute neutrophil count (ANC) ≥ 1000 cells/mm3 Platelet count ≥ 100,000/mm3 Hemoglobin ≥ 8 g/dL
Blood chemistry levels defined as:
AST, ALT, alkaline phosphatase ≤ 5 times upper limit of normal (ULN) Total bilirubin ≤ 2 times ULN Creatinine ≤ 2 times ULN 10. Anticipated life expectancy ≥ 3 months 11. Able to remain motionless for up to 30-60 minutes per scan
1. Completion of entry into \[68Ga\]Ga DOTA-5G PET study and completion of scan
2. The presence of at least one measurable disease by \[68Ga\]Ga DOTA-5G PET/CT (SUVmax\>2-fold above normal bone, brain, lung or liver and identified on standard of care diagnostic imaging)
Exclusion Criteria
2. Clinically significant bleeding within two weeks prior to trial. entry (e.g. gastrointestinal bleeding, intracranial bleeding)
3. Pregnant or lactating women
4. Major surgery, defined as any surgical procedure that involves general anesthesia and a significant incision (i.e., larger than what is required for placement of a central venous access, percutaneous feeding tube, or biopsy) within 28 days prior to study day 1 or anticipated surgery within the subsequent 6 weeks
5. Has an additional active malignancy requiring therapy within the past 2 years (other than early stage, surgically managed basal and squamous skin cancer and in situ malignancies of the breast and cervix)
6. Active, uncontrolled bacterial, viral, or fungal infection(s) despite systemic therapy
7. Psychiatric illness/social situations that would interfere with compliance with study requirements
8. Cannot undergo PET/CT or SPECT/CT scanning because of weight limits (350 lbs.)
9. Pathologically confirmed NSCLC with metastatic disease
10. INR \>2.0: PTT\>15 seconds above ULN
11. Participant on therapeutic warfarin anticoagulation
12. External beam radiation therapy (EBRT) or radiopharmaceutical treatment within 21 days prior to study day 1
18 Years
ALL
No
Sponsors
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National Institutes of Health (NIH)
NIH
University of California, Davis
OTHER
Responsible Party
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Julie L. Sutcliffe, Ph.D
Professor
Principal Investigators
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Julie L Sutcliffe
Role: PRINCIPAL_INVESTIGATOR
University of California, Davis
Locations
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The University of California Davis Comprehensive Cancer Center
Sacramento, California, United States
Countries
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Central Contacts
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Facility Contacts
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Julie L Sutcliffe, PhD
Role: primary
Other Identifiers
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1788760
Identifier Type: -
Identifier Source: org_study_id